BEUDAMED
    Product Code: QTE FDA class 2 21 CFR 866.6010

    Thymidine Kinase Activity

    Immunology

    The Thymidine Kinase Activity test is an in vitro diagnostic device that measures thymidine kinase activity (TKa) in patient samples to aid in monitoring disease progression in breast cancer patients. Elevated thymidine kinase activity is a marker associated with active cell proliferation and tumor burden. Classified as FDA Class 2 under regulation 866.6010, it requires 510(k) clearance in the Immunology specialty. The device is not an implant and not life-sustaining.

    View on FDA
    510(k)s
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    QTE
    Device Class
    FDA class 2
    Regulation Number
    866.6010
    Medical Specialty
    Immunology
    Review Panel
    IM
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    In vitro test to measure thymidine kinase activity (TKa) to aid in monitoring disease progression of breast cancer patients.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 1 510(k) clearance via K numbers.

    K Number Device Name
    K202852 DiviTum TKa

    FEI Numbers

    This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.